Regulatory Recon: FDA Approves Aerie's Glaucoma Drug US Lifts Funding Ban on High Risk Virus Research (19 December 2017)

Posted 19 December 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Aerie's Glaucoma Drug US Lifts Funding Ban on High Risk Virus Research (19 December 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Aerie's glaucoma treatment gets early FDA approval (Reuters) (Endpoints) (Press)
  • Dr. Reddy's resolves US probe over child safety of drug packaging (Reuters) (Economic Times)
  • US lifts moratorium on funding controversial, high-risk virus research (STAT)
  • Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill (Focus)
  • FDA Plots New Enforcement Approach for Homeopathic Products (Focus) (FDA)
  • How to watch this week's shutdown fight (Politico)
  • Amazon Hasn't Figured Out Drugstores Yet. But It Will Have To (Bloomberg)
  • FDA Adds New Warning For Gadolinium-based Contrast Agents (FDA)
  • Stepping up behind Sanofi, Genentech rolls the DiCE on a new small molecule discovery pact (Endpoints) (Fierce) (Press)
  • Array joins Pfizer on anti-cancer combos, the latest in a string of binimetinib combinations (Endpoints)
  • Time For Big Pharma To Step Up Before The Drug Price Debate Rises Again (Forbes)
  • Shire hit by a setback as Hunter syndrome drug fails late-stage study (Endpoints) (Reuters)
  • Drug makers detest patent reviews, but what are the odds of success? (STAT)
  • For biotech analysts, the outlook for 2018 is dark and stormy (STAT)
  • Drug Industry Spent Millions To Squelch Talk About High Drug Prices (KHN)
  • Three Major New York Diagnostic Testing Facility Owners Charged for Their Roles in Alleged Multi-Million Dollar Health Care Fraud Scheme (DoJ)
  • Tribe, Generics Spar Over PTAB Amici In Allergan Patent Row (Law360-$)
  • Gene Editing Could Rewrite the GMO Debate (MIT Technology Review)

In Focus: International

  • Roche touts Swiss-led R&D unit after years in Genentech's shadow (Reuters) (Endpoints)
  • Israel's Netanyahu to Try Persuading Teva Chief to Limit Firings (Bloomberg)
  • Teva's new launches won't feel the sting of hefty cost cuts: CEO (Fierce)
  • Takeda's off-the-shelf stem cell therapy closes in on EU approval (BioPharmaReporter) (EPVantage)
  • China accounts for 66 per cent of India's bulk drug imports in FY'17 (Economic Times)
  • EMA Adopts ICH Guideline on Multi-Region Clinical Trials (FDANews-$)
  • NHS England approves three new specialised treatments (PharmaTimes)
  • UK Life Science 'Needs Manufacturing Incentives, NHS Access' After Brexit (SCRIP-$)
  • 100,000 vacancies contribute to NHS crisis (Pharmafile)
  • Boehringer Ingelheim signs Evox, Roche deals (PharmaTimes)
  • UK's MHRA: Apotex Site Does Not Comply With GMP Requirements (Focus)
  • Canadians consumed C$5 billion to C$6.2 billion in cannabis in 2015 (Reuters)
  • Hikma wins right to market Roche drug copy in Middle East and North Africa (Reuters)
  • Gilead faces a hepatitis C patent challenge in China by Doctors Without Borders (STAT)
  • Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits (WHO)
  • European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices (Emergo)

Pharmaceuticals & Biotechnology

  • The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President's Commission on Combating Drug Addiction Misinterpreted Scientific Studies (Harvard Bill of Health)
  • Anti-opioid vaccine could offer bridge to overcoming addiction (Fierce)
  • Use of Standards at CBER: New Draft Guidance (Focus)
  • Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics (Focus)
  • Drug Channels Outlook: What to Watch in 2018 (Drug Channels)
  • Bisaro, Amneal poach top Allergan exec for CEO's chair (Fierce)
  • Regulatory Intelligence Brief: 2017 FDA Overview (PharmaManufacturing)
  • P&G investors wish for CEO Joe Jimenez as outgoing Novartis chief joins board (Fierce)
  • Probiotics and xylitol don't help sore throats (Reuters)
  • Fight The Opioid Epidemic, All Agree. But Strategies Vary Widely (NPR)
  • How A Leading Journal Helped A Pharma Company Exaggerate Medication Benefits (Forbes)
  • More Generic Drug Approvals Could Help Lower Prices: HealthLeaders Media (Medpage)
  • Antibiotics could dramatically reduce STIs, study says, raising tough new questions (STAT)
  • FDA Cannot Remain MIA As States', Cities' Drug-Litigation Crusade Threatens Regulatory Uniformity (Forbes)
  • IL-18 Secreting CAR-T Cells Enhance Immune Killing Of Tumors (BioCentury)
  • FDA Provides Information on the Use of Medically Important Antimicrobials in Bees (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Prometic's Plasminogen (Ryplazim) granted orphan drug designation for the treatment of idiopathic pulmonary fibrosis (IPF) (Press)

Medical Devices

  • Complying with ISO 13485:2016's New Expectations for Supplier Management (MDDI)
  • Final Guidance from US FDA on Clinical Evaluation of Software as a Medical Device (SaMD) (Emergo)
  • Connected Drug-Devices: Ensuring Device Longevity and Success (MDDI)
  • Medical Devices: General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss (FDA)
  • McKesson wins $400m maximum digital imaging, archiving DoD contract (MassDevice)
  • Glaukos to Begin Randomized U.S. IDE Pivotal Clinical Trial for the iStent SA System (Press)
  • Boston VC firm Vida Ventures unveils $255m healthcare fund (MassDevice)
  • Biom'Up wins FDA PMA nod for Hemoblast Bellows surgical hemostatic (MassDevice)
  • Bigfoot Biomedical's automated insulin delivery systems attract $37M in Series B funding (MobiHealthNews)
  • Mauna Kea wins expanded FDA 510(k) for Cellvizio (MassDevice)
  • Senzime wins CE Mark for OnZurf GI surgical probe (MassDevice)

US: Assorted & Government

  • Without the Insurance Mandate, Health Care's Future May Be in Doubt (NYTimes)
  • Hospital Giants Vie for Patients in Effort to Fend Off New Rivals (NYTimes)
  • Plaintiffs Have Burden To Plead Newly Acquired Evidence (Drug & Device Law)
  • Fed. Circ. Upholds Genzyme's Win In Stem Cell Patent Case (Law360-$)
  • In dispute with Amgen, Sandoz strikes up another victory for biosim compatriots (Fierce) (Law360-$)
  • PTAB To Rehear Cook Challenge To Internal-Bleed Device IP (Law360-$)
  • 2nd Circ. Affirms Dismissal Of FCA Suit Against Amgen (Law360-$)
  • Prevagen Maker Must Face Certified Class In Labeling Suit (Law360-$)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Second international awareness session for international regulators, academia and non-governmental organisations – 8-9 March 2018
  • New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop – 9 January 2018


  • EUnetHTA Magazine - Winter 2017 (EUnetHTA)
  • The impact of Brexit on life sciences (EPR)
  • The rare disease challenge: two decades since Europe passed legislation to develop and use orphan drugs, are we succeeding? (PharmaLetter-$)
  • With UK Pharma facing Brexit headwinds, could UK gov't defeat help industry by leading to a "softer" Brexit? (PharmaLetter-$)
  • Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b (EMA: First version, Annexes)


  • China's RDPAC Names Executive Committee (BioCentury)


  • Biocon to invest in Uttar Pradesh health sector (Economic Times)
  • Maha FDA conducts 60 workshops across state on good pharmaceutical practices (PharmaBiz)
  • Indian drugmakers making inroads into new CNS treatments (PharmaLetter-$)
  • NPPA notifies prices of 65 essential formulations (Economic Times)
  • Drug companies fear double tax on old stocks (Economic Times)
  • Lincoln Pharma gets patent for anti-malarial drug (Economic Times)



  • TGA operations over the holiday period 2017-18 (TGA)
  • Autologous cell and tissue products (TGA)
  • DarioHealth wins Australian approval for glucose meters designed for latest iPhones (Drug Delivery)

General Health

  • Preemies and underweight babies more likely to develop ADHD (Reuters)
  • Exercise, pills, brain training show little hard evidence of slowing dementia (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles